The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow.
Female urinary incontinence is a common medical condition, having widespread economic and social ramifications. The difficulty and embarrassment associated with urinary incontinence often causes the affected person to limit her social activities. In some cases, pads or diapers are used to absorb the uncontrolled seepage of urine. These absorbent items must be changed frequently, creating an ongoing economic burden. The wearing of absorbent undergarments may also restrict the type or style of clothing which the patient may wear. More seriously, skin irritation and other hygienic difficulties often result from the lingering presence of captured urine against tender urogenital tissues.
An additional method of treating urinary incontinence is the use of bladder flow control devices, sometimes referred to as artificial sphincters or prosthetic urethral valves. A bladder flow control device may be positioned in the urethra of a patient to control the flow of urine out of the bladder. It is desirable for the placement of the bladder flow control apparatus in the urethra to be performed easily and non-surgically. Once the bladder flow control device is placed, it is desirable that it be safely and securely retained in the urethra. Optimally, the device surfaces which contact the human body will be formed of biocompatible materials, to lessen chances of inflammation in patients.
The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to an intraurethral device including a sheath having a distal portion and a proximal portion. The sheath includes a proximal retainer disposed proximate its proximal end. The proximal retainer serves to prevent distal motion of the sheath into the patient by lying against the urethral labia. The sheath further includes a sheath wall defining a central lumen. A flow control valve unit is disposed in the lumen of the sheath.
An intraurethral device in accordance with the present invention, further includes a distal member having a distal tip and a proximal portion. The proximal portion of the distal member is fixed to the distal portion of the sheath by a linking means. In one embodiment of the present invention, the linking means includes an elastomer hinge. When the elastomer hinge is in a natural, undeformed state, the central axis of the distal member of the intraurethral device is positioned at an angle to the central axis of the sheath. The distal member of the intraurethral device may be urged into axial alignment with the sheath by deforming the elastomer hinge.
In a presently preferred method in accordance with the present invention, the distal member is urged into axial alignment with the sheath during insertion of the intraurethral device into the urethra of a patient. In this presently preferred method, the intraurethral device is inserted into the urethra of the patient until the distal member is free to assume a misaligned position. In this misaligned position, the elastomer hinge assumes its natural, undeformed state. When the distal member of the intraurethral device assumes this misaligned position, the distal member serves to prevent proximal motion of the sheath out of the patient by contacting the bladder floor. Distal motion of the sheath into the patient is prohibited by the proximal retainer disposed at the proximal end of the sheath. In this manner, the intraurethral device is held within the urethra by the distal member and the proximal retainer acting at opposite ends of the urethra.
An insertion tool is also provided. The insertion tool includes a shaft having a distal end and a proximal end. The distal end of the shaft is adapted to selectively form a connection with a proximal end of the flow control valve unit disposed in the lumen of the sheath. The shaft of the insertion tool provides a convenient location to grasp the assembly. The use of an insertion tool minimizes the risk of infection by minimizing human contact with the intraurethral device.